Efficacy and Safety Study of 610 in Patients With Severe Asthma

Asthma Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323213
• Other study ID #: SSGJ-610-BA-III-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2024
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: Qinghong Zhou, MD
• Phone: +86 18911301578
• Email: zhouqinghong[@]3sbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.

Description:

The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: September 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Able to give written informed consent prior to participation in the study.

2. Male or female adults ages 18 to 75 years old when signing the informed consent.

3. Documented diagnosis of asthma for at least one year prior to screening.

4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.

Exclusion Criteria:

1. Presence of a known pre-existing, clinically important lung condition other than asthma.

2. Severe asthma exacerbation within 4 weeks prior to randomization.

3. Subjects with any eosinophilic diseases other than asthma.

4. Known, pre-existing severe or clinically significant cardiovascular disease.

5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.

6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.

7. Subjects with allergy/intolerance to a monoclonal antibody.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 610
610 subcutaneously injection.
• Placebo
Placebo subcutaneously injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized rate of severe exacerbation events	Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period	Up to 52 weeks
Secondary	Time to first severe exacerbation event	Time to first severe exacerbation event during the 52-week placebo-controlled treatment period	Up to 52 weeks
Secondary	Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit	Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 52-week placebo-controlled treatment period	Up to 52 weeks
Secondary	Change from baseline in ACQ score	Change from baseline to week 52 in ACQ score	Up to 52 weeks
Secondary	Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)	Change from baseline to week 52 in SGRQ score	Up to 52 weeks
Secondary	Change in pre-bronchodilator forced expiratory volume (FEV1)	Absolute change from baseline to week 52 in pre-bronchodilator FEV1	Up to 52 weeks
Secondary	Assessment of adverse events (AEs)	Number of participants with adverse events (AEs)	Up to 60 weeks